Study of Leukocyte Immunophenotype and the Lipid Transport System as Predictive Biomarkers of Severe Bacterial Infections

Sepsis Clinical Trial

Official title:

Study of Leukocyte Immunophenotype and the Lipid Transport System as Predictive Biomarkers of Severe Bacterial Infections

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04178915
• Other study ID #: RRPCEM_bacterial
• Status: Enrolling by invitation
• Start date: July 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2023
• Source: The Republican Research and Practical Center for Epidemiology and Microbiology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Current study evaluates the relationship between cell immunity and lipid transport systems in patients with severe bacterial infections (on the model of pneumonia, infective endocarditis, sepsis) in order to develop new methods for predicting the course and outcome of severe bacterial infections.

Description:

• To study the state of the immune system in patients with severe bacterial infections (on the model of pneumonia, infective endocarditis, sepsis): spontaneous and stimulated production of reactive oxygen species by blood neutrophils; spontaneous necroptosis, apoptosis and pyroptosis of neutrophils; the content of blood leukocyte subpopulations.

• Assess the clinical, biochemical status, state of the lipid transport system of patients with severe bacterial infections (in the model of pneumonia, infective endocarditis, sepsis), including determination of the cholesterol content in the cell membrane of T-cells and monocytes.

• To develop a method for predicting an unfavorable course and an algorithm for the treatment (immunocorrection) of severe bacterial infections (on the model of pneumonia, infectious endocarditis, sepsis) based on the determination of the clinical and immunological status, indicators of the lipid transport system and dysmetabolic disorders, and propose a correction method for the treatment of these diseases, supplementing existing clinical protocols (preparations of immunoglobulins, lipids for parenteral nutrition, possibly PCSK9 inhibitors).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• community-acquired pneumonia, severe course (according to IDSA / ATs criteria) and / or sepsis with different localization of the primary focus (SOFA> 2);

• the patient's ability to comply with the instructions of the research doctor and follow the procedures required by the test protocol;

• informed consent.

Exclusion Criteria:

• acute and chronic heart failure;

• renal failure;

• acute and chronic liver failure;

• taking medications of the statin group during the last month before the study;

• diabetes in the stage of clinical and metabolic decompensation;

• acute and chronic leukemia, severe anemia;

• pregnancy or lactation;

• HIV infection;

• drug addiction;

• immunosuppressive therapy;

• malignant neoplasms over the past 5 years.

Related Conditions & MeSH terms

• Bacterial Infections
• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis
• Pneumonia, Bacterial
• Sepsis

Intervention

Diagnostic Test:
• Bood leukocyte subsets
Determination of blood leukocyte subpopulations, myeloid suppressor cells of various origins, type 2 congenital lymphoid cells, depleted T cells, CD45RA+ CD45RB+ CD62L-IRC, T-cell differentiation stages (naive - memory cells - effector - terminally differentiated effectors), B cells (CD5+ B1 cells, CD11c+ ABC, differentiation stages: immature - naive - isotype-unswitched memory cells - isotype-switched memory cells - plasmoblast)
• The cholesterol content of the cell membrane of T-cells and monocytes
The cholesterol content of the cell membrane of T-cells and monocytes with flow cytometry analysis

Locations

Country	Name	City	State
Belarus	The Republican Research and Practical Center for Epidemiology and Microbiology	Minsk

Sponsors (2)

Lead Sponsor	Collaborator
The Republican Research and Practical Center for Epidemiology and Microbiology	Belarusian State Medical University

Country where clinical trial is conducted

Belarus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate		1 month